SUPPLY CHAIN ARTICLES

  • From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

    In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

  • Can America's Retreat On mRNA Be Europe's Opportunity?

    With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

  • Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  • The mRNA Supply Chain Revolution: Materials, Methods, And Momentum

    mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.

  • Inside Alnylam's Playbook For High Volume siRNA Production

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

SUPPLY CHAIN VIDEOS

Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants? 

In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.

Explore two functional areas that Advancing RNA panelists consider most essential to telling an RNA product’s “story” thoroughly to regulators.

We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA. 

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS